Biopsy device tissue sample holder with bulk chamber and pathology chamber

ABSTRACT

A biopsy device includes a probe, a holster, and a tissue sample holder for collecting tissue samples. The probe includes a needle and a hollow cutter. The tissue sample holder includes a housing having one or more chambers that are configured to receive a removable tray including one or more prongs and a bulk chamber of a different volume than the one or more chambers. The housing is releasably engageable with the probe. Each tray prong is configured to receive a tissue sample communicated through the cutter lumen. The tray is removable from the housing, such as along an axial direction. The tissue sample holder is rotatable to successively index each chamber to the cutter lumen. The trays may be flexible, resilient, or rigid.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, or otherwise. For instance, some biopsy devicesmay be fully operable by a user using a single hand, and with a singleinsertion, to capture one or more biopsy samples from a patient. Inaddition, some biopsy devices may be tethered to a vacuum module and/orcontrol module, such as for communication of fluids (e.g., pressurizedair, saline, atmospheric air, vacuum, etc.), for communication of power,and/or for communication of commands and the like. Other biopsy devicesmay be fully or at least partially operable without being tethered orotherwise connected with another device.

Merely exemplary biopsy devices are disclosed in U.S. Pat. No.5,526,822, entitled “Method and Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,086,544, entitled “Control Apparatus for an Automated Surgical BiopsyDevice,” issued Jul. 11, 2000; U.S. Pat. No. 6,626,849, entitled “MRICompatible Surgical Biopsy Device,” issued Sep. 30, 2003; U.S. Pub. No.2006/0074345, entitled “Biopsy Apparatus and Method,” published Apr. 6,2006; U.S. Pat. No. 7,442,171, entitled “Remote Thumbwheel for aSurgical Biopsy Device,” issued Oct. 28, 2008; U.S. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008; U.S. Pat. No. 7,854,706, entitled “Clutch andValving System for Tetherless Biopsy Device,” issued Dec. 21, 2010; U.S.Pub. No. 2010/0152610, entitled “Hand Actuated Tetherless Biopsy Devicewith Pistol Grip,” published Jun. 17, 2010; U.S. Pub. No. 2010/0160819,entitled “Biopsy Device with Central Thumbwheel,” published Jun. 24,2010; U.S. Pub. No. 2010/0160824, entitled “Biopsy Device with DiscreteTissue Chambers,” published Jun. 24, 2010; U.S. Pub. No. 2010/0317997,entitled “Tetherless Biopsy Device with Reusable Portion,” publishedDec. 16, 2010; U.S. Non-Provisional patent application Ser. No.12/953,715, entitled “Handheld Biopsy Device with Needle Firing,” filedNov. 24, 2010; and U.S. Non-Provisional patent application Ser. No.13/086,567, entitled “Biopsy Device with Motorized Needle Firing,” filedApr. 14, 2011. The disclosure of each of the above-cited U.S. patents,U.S. patent application Publications, and U.S. Non-Provisional patentapplications is incorporated by reference herein.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventor hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements. In thedrawings some components or portions of components are shown in phantomas depicted by broken lines.

FIG. 1 is a schematic view of an exemplary biopsy system;

FIG. 2 is a block schematic diagram showing various components of anexemplary biopsy device;

FIG. 3 is a perspective view of a holster and a probe of an exemplarybiopsy device coupled together, the probe including a tissue sampleholder;

FIG. 4 is a perspective view of the biopsy device of FIG. 3, showing theprobe separated from the holster to expose an underside of the probe anda top side of the holster;

FIG. 5 is an end view of an example of an inner housing for the tissuesample holder of FIG. 3 attached to an end of the probe of FIG. 3,showing a tissue sample entry point of the probe, a bulk chamber withinthe inner housing, and a tray receiving chamber within the innerhousing;

FIG. 6 is a perspective view of the proximal end of the inner housing ofFIG. 5 and a removable tray that is received in the tray receivingchamber of FIG. 5;

FIG. 7 is a perspective view of the distal end of the inner housing andremovable tray of FIG. 6;

FIG. 8 is an exploded perspective view of the inner housing andremovable tray of FIG. 6;

FIG. 9 is an end view of another example of an inner housing for thetissue sample holder of FIG. 3 attached to an end of the probe of FIG.3, showing a tissue sample entry point of the probe, a bulk chamberwithin the inner housing, and tray receiving chambers within the innerhousing;

FIG. 10 is a perspective view of the distal end of the inner housing ofFIG. 9 and a removable tray that is received within the tray receivingchambers of FIG. 9;

FIG. 11 is an exploded perspective view of the inner housing andremovable tray of FIG. 10;

FIG. 12 is a perspective view of the proximal end of another example ofan inner housing for the tissue sample holder of FIG. 3;

FIG. 13 is an exploded view of the tissue sample holder of FIG. 3,showing the inner housing of FIG. 12, a two-prong tray, a marker and/ormedication seal plug, a bulk chamber cap, a gear shaft, and an outercup;

FIG. 14 is a perspective, assembled view of the tissue sample holder ofFIG. 13;

FIG. 15 is a perspective view of the proximal end of another example ofan inner housing for the tissue sample holder of FIG. 3;

FIG. 16 is an exploded view of the tissue sample holder of FIG. 3,showing the inner housing of FIG. 16, a single prong tray, a markerand/or medication seal plug, a bulk chamber cap, a gear shaft, and anouter cup;

FIG. 17 is a perspective view of the proximal end of another example ofan inner housing for the tissue sample holder of FIG. 3; and

FIG. 18 is an exploded view of the tissue sample holder of FIG. 3,showing the inner housing of FIG. 17, a plurality of single-prong trays,a marker and/or medication seal plug, a bulk chamber cap, and a gearshaft.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Biopsy Device

As shown in FIG. 1, an exemplary biopsy system (2) includes a biopsydevice (10) and a vacuum control module (1400). As shown in FIGS. 3-4,biopsy device (10) comprises a probe (100), a holster (700), and atissue sample holder (300). As will be described in greater detail belowand as shown in FIG. 4, probe (100) is separable from its correspondingholster (700).

By way of example only, probe (100) may be provided as a disposablecomponent, while holster (700) may be provided as a reusable component.Vacuum control module (1400) is provided on a cart (not shown) in thepresent example, though like other components described herein, a cartis merely optional. A control module interface (not shown) may also beprovided between biopsy device (10) and vacuum control module (1400),for providing electrical and mechanical communication to biopsy device(10); as well as electrical communication with vacuum control module(1400). By way of example only, control module (1400) may be constructedand operable in accordance with at least some of the teachings of U.S.Patent App. Publ. No. 2008/0214955, entitled “Presentation of BiopsySample by Biopsy Device”, published Sep. 4, 2008, the disclosure ofwhich is incorporated by reference herein. Among other componentsdescribed herein, a footswitch (not shown) and/or other devices may beused to provide at least some degree of control of at least a portion ofbiopsy system (2). As shown in FIG. 1, conduits (1200) providecommunication of power (e.g., mechanical such as through a cable,electrical, pneumatic, etc.), control signals, saline, vacuum, andventing from vacuum control module (1400) to biopsy device (10). Each ofthese components will be described in greater detail below.

FIGS. 2-4 show an exemplary biopsy device (10). As described above,biopsy device (10) of this example comprises a probe (100) and a holster(700). Referring to FIGS. 3-4, a needle (110) extends distally fromprobe (100), and is inserted into a patient's tissue to obtain tissuesamples as will be described in greater detail below. These tissuesamples are deposited in a tissue sample holder (300) at the proximalend of probe (100), as will also be described in greater detail below.It should also be understood that the use of the term “holster” hereinshould not be read as requiring any portion of probe (100) to beinserted into any portion of holster (700). While prongs (102) are usedto removably secure probe (100) to holster (700) in the present example,as shown in FIG. 4, it should be understood that a variety of othertypes of structures, components, features, etc. (e.g., bayonet mounts,latches, clamps, clips, snap fittings, etc.) may be used to provideremovable coupling of probe (100) and holster (700). Furthermore, insome biopsy devices (10), probe (100) and holster (700) may be ofunitary or integral construction, such that the two components cannot beseparated. By way of example only, in versions where probe (100) andholster (700) are provided as separable components, probe (100) may beprovided as a disposable component, while holster (700) may be providedas a reusable component. Still other suitable structural and functionalrelationships between probe (100) and holster (700) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

Some variations of biopsy device (10) may include one or more sensors(not shown), in probe (100) and/or in holster (700), that is/areconfigured to detect when probe (100) is coupled with holster (700).Such sensors or other features may further be configured to permit onlycertain types of probes (100) and holsters (700) to be coupled together.In addition or in the alternative, such sensors may be configured todisable one or more functions of probes (100) and/or holsters (700)until a suitable probe (100) and holster (700) are coupled together. Ofcourse, such sensors and features may be varied or omitted as desired.

In some versions as shown in FIG. 2, biopsy device (10) includes avacuum source (800), such as a vacuum pump. By way of example only,vacuum source (800) may be incorporated into probe (100), incorporatedinto holster (700), and/or be a separate component altogether. Inversions where vacuum source (800) is separate from probe (100) andholster (700), vacuum source (800) may be coupled with probe (100)and/or holster (700) via one or more conduits such as flexible tubing(1402, 1408) (shown in the example of FIG. 1 as vacuum control module(1400) and conduit (1200) and as described in detail further below). Asshown in FIG. 2, vacuum source (800) is in fluid communication withtissue sample holder (300) and needle (110). Thus, vacuum source (800)may be activated to draw tissue into lateral aperture (114) of needleportion or needle (110). Tissue sample holder (300) is also in fluidcommunication with cutter (200). Vacuum source (800) may thus also beactivated to draw severed tissue samples through the hollow interior ofcutter (200) and into tissue sample holder (300). Other suitable ways inwhich vacuum source (800) may be used will be apparent to those ofordinary skill in the art in view of the teachings herein. It shouldalso be understood that vacuum source (800) may simply be omitted, ifdesired.

In some versions, vacuum source (800) is provided in accordance with theteachings of U.S. Pub. No. 2008/0214955, the disclosure of which wasincorporated by reference above. In addition or in the alternative,vacuum source (800) may be provided in accordance with the teachings ofU.S. Non-Provisional patent application Ser. No. 12/953,715, thedisclosure of which is incorporated by reference above. As yet anothermerely illustrative example, vacuum source (800) may be provided inaccordance with the teachings of U.S. Non-Provisional patent applicationSer. No. 12/709,695, entitled “Biopsy Device with Auxiliary VacuumSource,” filed Feb. 22, 2010, the disclosure of which is incorporated byreference herein. Still other suitable ways in which vacuum source (800)may be provided will be apparent to those of ordinary skill in the artin view of the teachings herein.

Biopsy device (10) of the present example is configured to mount to atable or fixture, and be used under stereotactic guidance. Of course,biopsy device (10) may instead be used under ultrasound guidance, MRIguidance, PEM guidance, BSGI guidance, or otherwise. It should also beunderstood that biopsy device (10) may be sized and configured such thatbiopsy device (10) may be operated by a single hand of a user. Inparticular, a user may grasp biopsy device (10), insert needle (110)into a patient's breast, and collect one or a plurality of tissuesamples from within the patient's breast, all with just using a singlehand. Alternatively, a user may grasp biopsy device (10) with more thanone hand and/or with any desired assistance. In some settings, the usermay capture a plurality of tissue samples with just a single insertionof needle (110) into the patient's breast. Such tissue samples may bepneumatically deposited in tissue sample holder (300), and laterretrieved from tissue sample holder (300) for analysis. While examplesdescribed herein often refer to the acquisition of biopsy samples from apatient's breast, it should be understood that biopsy device (10) may beused in a variety of other procedures for a variety of other purposesand in a variety of other parts of a patient's anatomy (e.g., prostate,thyroid, etc.). Various exemplary components, features, configurations,and operabilities of biopsy device (10) will be described in greaterdetail below; while other suitable components, features, configurations,and operabilities will be apparent to those of ordinary skill in the artin view of the teachings herein.

As shown in FIG. 1, an exemplary vacuum canister (1500) is configured tobe coupled with vacuum control module (1400). Vacuum control module(1400) is operable to induce a vacuum through vacuum canister (1500),and such a vacuum may be communicated to biopsy probe (100). Forinstance, vacuum control module (1400) may communicate a vacuum throughtube (1404), which may then communicate the vacuum through tissue sampleholder (300) to a cutter lumen (not shown) of probe 100 as describedbelow. Vacuum control module (1400) may also communicate a vacuumthrough tube (1402) to a manifold of hub member or hub (150), as shownin FIGS. 3-4, which may then communicate the vacuum to a vacuum lumen(not shown) of outer cannula (111) of needle 110.

Furthermore, vacuum canister (1500) is operable to collect fluids thatare communicated from biopsy probe (100) during use of biopsy probe(100). Vacuum canister (1500) may thus be regarded as providing a fluidinterface between biopsy probe (100) and vacuum control module (1400).Any suitable vacuum control module and vacuum canister may be used suchas those described in U.S. Pub. 2008/0214955, entitled “Presentation ofBiopsy Sample by Biopsy Device,” published Sep. 4, 2008 and U.S. Pub.No. 2010/0160824, entitled “Biopsy Device with Discrete TissueChambers”, published Jun. 24, 2010, the disclosures of which areincorporated by reference herein. Further, any other suitable component,system, technique, or device may be used with the suitable controlmodule or vacuum canister.

As shown in FIG. 1, a tube (1408) is fed into tube (1402). Tube (1410)is also fed into tube (1402). In particular, a connector (1446) connectssaline tube (1408) with tube (1402). As shown, connector (1446) isprovided adjacent to canister (1500), while connector (1448) is providednear biopsy probe (100). In the present example, connectors (1446, 1448)simply provide a constantly open conduit between tubes (1410, 1402) andtubes (1408, 1402), respectively. In some other versions, connectors(1446, 1448) may have any other suitable components (e.g., valve, etc.).It will be appreciated in view of the disclosure herein that theconfiguration of tubes (1402, 1408, 1410) and connectors (1446, 1448)permits any of a vacuum, vent, or saline to be communicated through tube1402). An exemplary determination of which of these will be communicatedthrough tube (1402) will be described in greater detail below. As alsoshown, saline bag (1444) is coupled with tube (1408) using any suitableconventional fitting.

Vacuum control module (1400) of the present example may also include acontroller (1480) operable to control motors in holster (700). By way ofexample only, control module (1400) may be constructed and operable inaccordance with at least some of the teachings of U.S. Pat. No.7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device”, issuedMay 10, 2011, the disclosure of which is incorporated by referenceherein. Other suitable ways in which vacuum, saline, other fluids,and/or control may be provided will be apparent to those of ordinaryskill in the art in view of the teachings herein.

II. Exemplary Probe

As shown in FIGS. 2-4, probe (100) of the present example includes adistally extending needle (110). Probe (100) also includes a chassis(120) and a top housing (130), which are fixedly secured together. Asbest seen in FIG. 4, a gear (140) is exposed through an opening (142) inchassis (120), and is operable to drive cutter actuation mechanism (202)(FIG. 2) in probe (100). As also seen in FIG. 4, another gear (144) isexposed through another opening (146) in chassis (120), and is operableto rotate needle (110). Gear (140) of probe (100) meshes with exposedgear (740) of holster (700) when probe (100) and holster (700) arecoupled together. Similarly, gear (144) of probe (100) meshes withexposed gear (744) of holster (700) when probe (100) and holster (700)are coupled together.

As will be explained in more detail below, tissue sample holder (300) isremovably secured to a rear member of probe (100), though tissue sampleholder (300) may alternatively be secured to some other component ofprobe (100). As described above, though not shown in FIGS. 2-4, a pairof tubes (1402, 1404) is coupled with probe (100) for providing fluidcommunication therewith.

Suitable configurations for probe (100) will be apparent to those ofordinary skill in the art in view of the teachings herein. For instance,probe (100) may be configured in accordance with any of the teachings inU.S. Patent App. Pub. No. 2008/0214955, entitled “Presentation of BiopsySample by Biopsy Device,” published Sep. 4, 2008, the disclosure ofwhich is incorporated by reference herein. Other ways in which probe(100) may be configured are disclosed in U.S. Patent App. Pub. No.2010/0160816, entitled “Mechanical Tissue Sample Holder IndexingDevice,” published Jun. 24, 2010, the disclosure of which isincorporated by reference herein; U.S. Patent App. Pub. No.2010/0160821, entitled “Biopsy Device With Sliding Cutter Cover,”published Jun. 24, 2010, the disclosure of which is incorporated byreference herein; U.S. Patent App. Pub. No. 2010/0160819, entitled“Biopsy Device With Central Thumbwheel,” published Jun. 24, 2010, thedisclosure of which is incorporated by reference herein; U.S.Non-Provisional patent application Ser. No. 13/086,567, entitled “BiopsyDevice with Motorized Needle Firing,” filed Apr. 14, 2011, thedisclosure of which is incorporated by reference herein; and/or U.S.Pub. No. 2010/0160824, entitled “Biopsy Device with Discrete TissueChambers,” published Jun. 24, 2010, the disclosure of which isincorporated by reference herein. Still other ways in which probe (100)may be formed, including alternative techniques, materials, andconfigurations, will be apparent to those of ordinary skill in the artin view of the teachings herein.

A. Exemplary Needle

Needle (110) of the present example includes a piercing tip (112), alateral aperture (114) located proximal to tip (112), and a hub member(150). Tissue piercing tip (112) is configured to pierce and penetratetissue, without requiring a high amount of force, and without requiringan opening to be pre-formed in the tissue prior to insertion of tip(112). Alternatively, tip (112) may be blunt (e.g., rounded, flat, etc.)if desired. Tip (112) may also be configured to provide greaterechogenicity than other portions of needle (110), providing enhancedvisibility of tip (112) under ultrasound imaging. By way of exampleonly, tip (112) may be configured in accordance with any of theteachings in U.S. Non-Provisional patent application Ser. No.12/875,200, entitled “Echogenic Needle for Biopsy Device,” filed Sep. 3,2010, the disclosure of which is incorporated by reference herein. Othersuitable configurations that may be used for tip (112) will be apparentto those of ordinary skill in the art in view of the teachings herein.

Lateral aperture (114) is sized to receive prolapsed tissue duringoperation of device (10). A hollow tubular cutter (200) having a sharpdistal edge (not shown) is located within needle (110). Cutter (200) isoperable to rotate and translate relative to needle (110) and pastlateral aperture (114) to sever a tissue sample from tissue protrudingthrough lateral aperture (114). For instance, cutter (200) may be movedfrom an extended position to a retracted position, thereby “opening”lateral aperture (114) to allow tissue to protrude therethrough; thenfrom the retracted position back to the extended position to sever theprotruding tissue. While lateral aperture (114) is shown oriented in anupward position in FIG. 3, it should be understood that needle (110) maybe rotated to orient lateral aperture (114) at any desired angularposition about the longitudinal axis of needle (110). Such rotation ofneedle (110) is facilitated in the present example by hub member (150).

Hub member (150) of the present example is overmolded about needle(110), such that hub member (150) and needle (110) rotate and translateunitarily with each other. By way of example only, needle (110) may beformed of metal, and hub member (150) may be formed of a plasticmaterial that is overmolded about needle (110) to unitarily secure andform hub member (150) to needle (110). Hub member (150) and needle (110)may alternatively be formed of any other suitable material(s), and maybe secured together in any other suitable fashion. Hub member (150)includes an annular flange (152) and a thumbwheel (154). Gear (144) isslidably and coaxially disposed on a proximal portion (150) of hubmember (150) and is keyed to hub member (150), such that rotation ofgear (144) will rotate hub member (150) and needle (110); yet hub member(150) and needle (110) may translate relative to gear (144). Gear (144)is rotatably driven by gear (744). Alternatively, needle (110) may berotated by rotating thumbwheel (154). Various other suitable ways inwhich manual rotation of needle (110) may be provided will be apparentto those of ordinary skill in the art in view of the teachings herein.It should also be understood that rotation of needle (110) may beautomated in various ways, including but not limited to the variousforms of automatic needle rotation described in various references thatare cited herein. Needle (110) may be translated longitudinally relativeto chassis (120) and top housing (130), particularly by a needle firingmechanism (400) (FIG. 2), for example.

It should be understood that, as with other components described herein,needle (110) may be varied, modified, substituted, or supplemented in avariety of ways; and that needle (110) may have a variety of alternativefeatures, components, configurations, and functionalities. A pluralityof external openings (not shown) may also be formed in needle (110), andmay be in fluid communication with a lumen (not shown). For instance,such external openings may be configured in accordance with theteachings of U.S. Pat. No. 7,918,804, entitled “Biopsy Device withVacuum Assisted Bleeding Control,” issued Apr. 5, 2011, the disclosureof which is incorporated by reference herein. Cutter (200) may alsoinclude one or more side openings (not shown). Of course, as with othercomponents described herein, such external openings in needle (110) andcutter (200) are merely optional. As yet another merely illustrativeexample, needle (110) may be constructed and operable in accordance withthe teachings of U.S. Patent App. Pub. No. 2008/0214955, entitled“Presentation of Biopsy Sample by Biopsy Device,” published Sep. 4,2008, the disclosure of which is incorporated by reference herein,and/or in accordance with the teachings of any other reference citedherein.

Probe (100) may also include a valve assembly in fluid communicationwith at least part of needle (110), selectively changing a pneumaticstate of at least part of needle (110) based on any suitable conditionssuch as the longitudinal position of cutter (200). By way of exampleonly, such a valve assembly may be constructed and operable inaccordance with the teachings of U.S. Pub. No. 2010/0317997, entitled“Tetherless Biopsy Device with Reusable Portion,” published Dec. 16,2010, the disclosure of which is incorporated by reference herein, andin accordance with the teachings of U.S. Non-Provisional patentapplication Ser. No. 12/953,715, entitled “Handheld Biopsy Device withNeedle Firing,” filed Nov. 24, 2010, the disclosure of which isincorporated by reference herein, or otherwise. In addition or in thealternative, valving may be provided by vacuum source (800) (FIG. 2)and/or a vacuum canister, such as is taught in U.S. Patent App. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008, the disclosure of which is incorporated byreference herein. Other suitable alternative versions, features,components, configurations, and functionalities of needle (110) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

B. Exemplary Cutter Actuation Mechanism

As noted above, cutter (200) is operable to rotate and translaterelative to needle (110) and past lateral aperture (114) to sever atissue sample from tissue protruding through lateral aperture (114).This action of cutter (200) is provided by a cutter actuation mechanism(202). Cutter actuation mechanism (202) is positioned mainly in probe(100) in the present example, though it should be understood that cutteractuation mechanism (202) may be positioned mainly in holster (700)and/or both in probe (100) and holster (700). Cutter actuation mechanism(202) includes meshing gears (140, 740), with gear (740) being driven bymotor (204). Motor (204) is located in holster (700) in the presentexample, though it should be understood that motor (204) mayalternatively be located in probe (100) and/or elsewhere.

By way of example only, cutter actuation mechanism (202) may beconstructed and operable in accordance with the teachings of U.S. PatentApp. Pub. No. 2008/0214955, the disclosure of which was incorporated byreference above. As another merely illustrative example, cutteractuation mechanism (202) may be constructed and operable in accordancewith the teachings of U.S. Pub. No. 2010/0317997, the disclosure ofwhich was incorporated by reference above. As yet another merelyillustrative example, cutter actuation mechanism (202) may beconstructed and operable in accordance with the teachings of U.S. PatentApp. Pub. No. 2010/0292607, entitled “Tetherless Biopsy Device withSelf-Reversing Cutter Drive Mechanism,” published Nov. 18, 2010, thedisclosure of which is incorporated by reference herein. Alternatively,cutter actuation mechanism (202) may be constructed in accordance withthe teachings of any other reference cited herein. It should also beunderstood that biopsy device (10) may be configured such that cutter(200) does not translate (e.g., such that cutter (200) merely rotates,etc.); or such that cutter (200) does not rotate (e.g., such that cutter(200) merely translates, etc.). As another merely illustrative example,cutter (200) may be actuated pneumatically in addition to or in lieu ofbeing actuated by mechanical components. Other suitable alternativeversions, features, components, configurations, and functionalities ofcutter actuation mechanism (202) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

C. Exemplary Cutter

A hollow cutter (200) is disposed within a cannula lumen of outercannula (111) in the present example. The interior of cutter (200)defines a cutter lumen, such that fluid and tissue may be communicatedthrough cutter (200) via the cutter lumen. As will be described ingreater detail below, cutter (200) is configured to rotate within thecannula lumen of outer cannula (111) and translate axially within thecannula lumen of outer cannula (111). In particular, cutter (200) isconfigured to sever a biopsy sample from tissue protruding throughtransverse aperture (114) of outer cannula (111). As will also bedescribed in greater detail below, cutter (200) is further configured topermit severed tissue samples to be communicated proximally through thecutter lumen. Merely illustrative examples of such severing and proximalcommunication are described in U.S. Pat. No. 5,526,822, entitled “Methodand Apparatus for Automated Biopsy and Collection of Soft Tissue,”issued Jun. 18, 1996, the disclosure of which is incorporated byreference herein, though any other suitable structures or techniques maybe used for severing and/or communicating tissue samples within a biopsysystem (2). Still other ways in which cutter (200) may be configured ortreated, including alternative techniques and materials, will beapparent to those of ordinary skill in the art in view of the teachingsherein.

D. Exemplary Tissue Sample Holder

Tissue sample holder (300) of the present example, described in greaterdetail below, comprises an outer cup (303) and a rotatable manifold orinner housing (304) that includes a plurality of chambers configured toreceive tissue samples that are severed by cutter (200) and communicatedproximally through the hollow interior of cutter (200). Tissue sampleholder (300) also includes one or more removable trays that permit auser to remove severed tissue samples from tissue sample holder (300)without having to remove tissue sample holder (300) from chassis (120).Tissue sample holder (130) may further include an inner housing orrotatable manifold, as described in detail below, that is in fluidcommunication with vacuum source (800) and cutter (200) and that isrotatable to successively index the chambers to cutter (200). Inparticular, the manifold is rotated by a tissue sample holder rotationmechanism (302), which is driven by a motor (301). It should beunderstood that at least part of tissue sample holder rotation mechanism(302) and/or motor (301) may be incorporated into probe (100), intoholster (700), or into both probe (100) and holster (700). It shouldalso be understood that some versions of tissue sample holder (300) maybe driven manually, pneumatically, or otherwise.

By way of example only, tissue sample holder (300) may be constructedand operable in accordance with the teachings of U.S. Pub. No.2008/0214955, the disclosure of which was incorporated by referenceabove. As another merely illustrative example, tissue sample holder(300) may be constructed and operable in accordance with the teachingsof U.S. Pub. No. 2010/0160824, entitled “Biopsy Device with DiscreteTissue Chambers,” published Jun. 24, 2010, the disclosure of which isincorporated by reference herein. As yet another merely illustrativeexample, tissue sample holder (300) may be constructed an operable inaccordance with the teachings of U.S. Pub. No. 2008/0221480, entitled“Biopsy Sample Storage,” published Sep. 11, 2008, the disclosure ofwhich is incorporated by reference herein.

Outer cup (303) of the examples disclosed herein has a cylindrical shapedefining a distal end and a proximal end, though any other suitableshapes or configurations may be used. Outer cup (303) is configured toengage probe (100) in a bayonet fashion, such that outer cup (303) maybe selectively removed from or secured to probe (100). Morespecifically, the distal end of outer cup (303) includes a plurality ofslots (305) capable of engaging protrusions (not shown) of probe (100)upon sufficient rotation of outer cup (303) relative to probe (100).Other suitable configurations for providing selective engagement betweenouter cup (303) and probe (100) will be apparent to those skilled in theart in view of the teachings herein. Additionally, cup (303) remainsstationary while housing (304) rotates within cup (303). Cup (303) mayalso provide additional sealing for tissue sample holder (302) as awhole. It should be understood, however, that like other componentsdescribed herein, cup (303) is merely optional and may be omitted orvaried in a number of ways if desired. Still other suitable ways inwhich tissue sample holder (300) may be constructed and operable will beapparent to those of ordinary skill in the art in view of the teachingsherein.

III. Exemplary Holster

As shown in FIGS. 3-4, holster (700) of the present example includes atop housing cover (702), side panels (704), and a housing base (706),which are fixedly secured together. As best seen in FIG. 4 and as notedabove, gears (740, 744) are exposed through top housing cover (702), andmesh with gears (140, 144) of probe (100) when probe (100) and holster(120) are coupled together. In particular, gears (740, 140) drive cutteractuation mechanism (202); while gears (744, 144) are employed to rotateneedle (110). Holster (700) also includes a firing rod (730) and fork(732), which couple with needle (110) and fire needle (110) distally aswill be described in greater detail below.

All motors (204, 304, 402) referred to herein are contained withinholster (700) in the present example and receive power from an externalsource via cable (720). In addition or in the alternative, data may becommunicated via cable (720) from holster (700) and/or to holster (700)as desired. In some other versions, motors (204, 304, 402) are poweredby one or more batteries located within holster (700) and/or probe(100). It should therefore be understood that, as with other componentsdescribed herein, cable (720) is merely optional. As yet another merelyillustrative variation, motors (204, 304, 402) may be poweredpneumatically, such that cable (720) may be substituted with a conduitcommunicating a pressurized fluid medium to holster (700). As stillother merely illustrative variation, cable (720) may include one or morerotary drive cables that are driven by motors (204, 304, 402) that arelocated external to holster (700). It should also be understood that twoor three of motors (204, 304, 402) may be combined as a single motor.Other suitable ways in which various mechanisms (202, 302, 400) may bedriven will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

A. Exemplary Needle Rotation Mechanism

As noted above, rotation of gear (744) provides rotation of needle (110)relative to probe (100). In the present example, gear (744) is rotatedby rotating knob (710). In particular, knob (710) is coupled with gear(744) by a series of gears (not shown) and shafts (not shown), such thatrotation of knob (710) rotates gear (744). A second knob (710) extendsfrom the other side of holster (700). By way of example only, such aneedle rotation mechanism may be constructed in accordance with theteachings of U.S. Pub. No. 2008/0214955, the disclosure of which isincorporated by reference herein. As another merely illustrativeexample, a needle rotation mechanism may be constructed in accordancewith the teachings of U.S. Pub. No. 2010/0160819, the disclosure ofwhich was incorporated by reference above. In some other versions,needle (110) is rotated by a motor. In still other versions, needle(110) is simply rotated by rotating thumbwheel (154). Various othersuitable ways in which rotation of needle (110) may be provided will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should also be understood that some versions may provide norotation of needle (110).

B. Exemplary Needle Firing Mechanism

Holster (700) of the present example further includes a needle firingmechanism (400), which is operable to fire needle (110) from a loadedposition. By way of example only, such firing may be useful in instanceswhere biopsy device (10) is mounted to a stereotactic table fixture orother fixture, with tip (112) adjacent to a patient's breast, such thatneedle firing mechanism (400) may be activated to drive needle (110)into the patient's breast. Needle firing mechanism (400) may beconfigured to drive needle (110) along any suitable range of motion, todrive tip (112) to any suitable distance relative to fixed components ofprobe (100). Needle firing mechanism (400) of the present example isactivated by activation buttons (760) and arming buttons (750).Activation buttons (760) comprise thin film switches presented on sidepanels (704) of holster (700). In some versions activations buttons(760) are on both sides of holster (700) while in other versionsactivation buttons (760) are either on just one side of holster (700) orare located elsewhere (e.g., remote user interface, at vacuum source(800) or elsewhere, etc.). Activation buttons (760) are operable toselectively activate motor (402) to load needle firing mechanism (400).Arming buttons (750) are also provided on both sides of holster (700) inthe present example, and are mechanically movable transversely relativeto side panels (704). Each arming button (750) includes a bellows (752)that provides a fluid tight seal with side panel (704). Of course,either type of button (750, 760) may have various other components,features, configurations, and operabilities.

In the present example, needle firing mechanism (400) is coupled withneedle (110) via a firing rod (732) and a firing fork (732). Firing rod(732) and firing fork (734) are unitarily secured together bycomplementary flats and a pin (738). Firing fork (732) includes a pairof prongs (734) that receive hub member (150) of needle (110)therebetween. Prongs (734) are positioned between annular flange (152)and thumbwheel (154), such that needle (110) will translate unitarilywith firing rod (730) and fork (732). Prongs (734) neverthelessremovably receive hub member (150), such that fork (732) may be readilysecured to hub member (150) when probe (100) is coupled with holster(700); and such that hub member (150) may be readily removed from fork(732) when probe (100) is decoupled from holster (700). Prongs (734) arealso configured to permit hub member (150) to rotate between prongs(734), such as when knob (710) is rotated to change the angularorientation of lateral aperture (114). Other suitable components,configurations, and relationships will be apparent to those of ordinaryskill in the art in view of the teachings herein. By way of exampleonly, needle firing mechanism (400) may be constructed and operable inaccordance with at least some of the teachings of U.S. Non-Provisionalpatent application Ser. No. 13/086,567, entitled “Biopsy Device withMotorized Needle Firing,” filed Apr. 14, 2011, the disclosure of whichis incorporated by reference herein. Various other suitable ways inwhich needle firing mechanism (400) may be fired will be apparent tothose of ordinary skill in the art in view of the teachings herein. Itshould also be understood that some versions may provide no firing ofneedle (110).

IV. Exemplary First Version of an Inner Housing for a Tissue SampleHolder

FIGS. 5-8 show an exemplary first version of an internal or innerhousing (304A) of tissue sample holder (300) of biopsy device (10). FIG.5 shows exemplary inner housing (304A) as including bulk chamber (308),and tray receiving/tissue sample chamber (345A). Exemplary inner housing(304A) is positioned over a tissue sample entry point or port (306),which is disposed at a distal end of probe (100), through which a tissuesample may be received. FIG. 5 also shows a vacuum port (307), which isdisposed at a distal end of probe (100). Inner housing (304A) is influid communication with vacuum source (800) via vacuum port (307).Vacuum is communicated through port (307) from vacuum source (800), thenthrough tissue ample holder (300) to port (306). Such communicationallows tissue to be drawn through a lumen of cutter (200), through exitport (306), and then into tissue sample holder (300).

Inner housing (304A) is rotatable within outer cup (303) of tissuesample holder (300) to index tissue sample chamber (345A) or bulkchamber (308) with port (306) and cutter (200). Additionally oralternatively, outer cup (303) may be omitted, and inner housing (304A)may be manually or automatically rotated to index tissue sample chamber(345A) with cutter (200). For example, rotation may be effected by motor(301) via a gear shaft, such as shaft (422) (see FIG. 13), connectableto intermeshing gears in probe (100) and holster (700) for operation bythe motor, disposed in probe (100) and/or holster (700). Rotation ofother examples inner housings of the present disclosure may be effectedin a similar manner.

As an example of rotation, tissue sample chamber (345A) of FIG. 5 may berotated along the direction of arrow (A), as well as in an oppositedirection, to be disposed over port (306) such that one or more tissuesamples may be received within tissue sample chamber (345A).Alternatively, tissue sample chamber (345A) of FIG. 5 may be rotated toa position in which tissue sample chamber (345A) is not disposed overport (306) such that one or more tissue samples are then received withinbulk chamber (308) via port (306). Vacuum port (307) of probe (100) mayinclude a filter or a screen to prevent tissue from clogging vacuum port(307) when bulk chamber (308) is indexed to port (306). In addition orin the alternative, probe (100) may include or communicate with apressure pump to provide a positive air pressure through vacuum port(307) to clear debris from vacuum port (307) and/or to clear afilter/screen positioned at vacuum port (307). It should also beunderstood that cup (303) may include a sump feature for removal ofexcess fluid, etc.

Referring to FIG. 6, inner housing (304A) includes outer annular wall(310) including exterior wall face (312), interior wall face (314), andouter annular ridge (316) projecting transversely from outer annularwall (310). Outer annular ridge (316) includes internal walls definingnotch (318), which is shown in this example to have a square shape butmay include other shapes, such as circular or triangular shapes orcombinations thereof. Further, while ridge (316) is shown to include asingle notch (318), ridge (316) may include multiple notches (318) ofsimilar or differing shapes and/or sizes. Notch (318) may receive acorresponding protrusion of the rotation assisting member of probe (100)described above, for example, to assist with the rotation of innerhousing (304A) with respect to probe (100) and/or holster (700).

Inner housing (304A) includes tissue sample chamber (345A) and bulkchamber (308), which are separated by walls (320, 322, 324). As shown inFIG. 7, interior faces of walls (320, 322, 324) face towards firstportion (326) of interior wall face (314) of outer annular wall (310)and, with first portion (326), define tissue sample chamber (345A).Exterior faces of walls (320, 322, 324) face towards second portion(328) of interior wall face (314) of outer annular wall (310) and, withsecond portion (328), define bulk chamber (308).

Walls (320, 322) project inwardly from interior wall face (314) of outerannular wall (310) of inner housing (304A), and wall (324) is disposedbetween end portions of walls (320, 322). While wall (324) is shown asan arcuately shaped inner member, wall (324) may be formed to includeany other suitable sizes and shapes. Alternatively, wall (324) may beomitted such that walls (320, 322) meet at a point and form a triangularshape, as shown in FIG. 12 in a variation that is discussed in greaterdetail below.

In the present example, each of walls (320, 322, 324) include an upper,proximal portion and a lower, distal portion. Upper, proximal portion(330) of centrally disposed wall (324) is separated from lower, distalportion (332) of wall (324) by ledge (334). Lower, distal portions ofinwardly projecting walls (320, 322) have a width that is greater thanthe width of upper, proximal portions of walls (320, 322) by thedistance that upper and lower portions of centrally disposed wall (324)are separated by ledge (334).

Referring to FIG. 7, interior faces of inwardly projecting walls (320,322) each include front portion (F), rear portion (R), and alongitudinally extending protrusion (336). In the example shown in FIG.7, protrusions (336) internally extend from the upper portion of each ofwalls (320, 324). Protrusions may alternatively or additionally extendfrom other walls described within the scope of this disclosure.Elongated protrusions (336), rear portions (R) of the interior faces ofwalls (320, 322), and interior wall face (314) of outer annular wall(310) define a distal end of tray space (338) for receiving andretaining removable tray (340). As shown in FIG. 8, the rear portions ofthe interior faces of walls (320, 322), interior wall face (314) ofouter annular wall (310), and the interior face of the upper portion ofcentrally disposed wall (324) together define a proximal end of trayspace (338) to receive removable tray (340).

Tray (340), as shown in FIG. 8, includes handle (342) proximallyextending from arcuate and elongate proximal end wall (344), which has aproximal edge and a distal edge. Handle (342) may assist a user withinserting or removing tray (340) from tray space (338); and withmanually rotating inner housing (304A) when tray (340) is receivedwithin tray space (338). Sidewalls or outer tray walls (346, 348),having proximal and distal edges, project distally from an underside ordistal edge of proximal end wall (344). Elongate arcuate walls (350,352) are disposed below and proximate to proximal end wall (344) andhave substantially the same shape as proximal end wall (344). Peripheralends of proximal end wall (344) and elongate arcuate walls (350, 352)act as wiper seals providing an additional seal between the proximal endof tray (340) and tissue sample chamber (345A) when tray (340) isreceived in tray space (338) of tissue sample chamber (345A) to preventpotential seepage of tissue sample fluid or the tissue sample; and alsohelp to maintain a vacuum within chamber (345A). The peripheral endsmay, for example, form a frictional fit with the walls defining trayspace (338) of inner housing (304A). Tray (340) and/or other componentsof tissue sample holder (300) may also include face seals and/or varioustypes of elastomers to create a seal. Additionally or alternatively,peripheral opposite side ends of one or more of walls (344, 350, 352)may be received with apertures (354) defined in a proximal portion ofwalls (320, 322).

Arcuately shaped floor (356) is disposed between outer tray walls (346,348) and includes apertures (358). At a distal end, base end wall (360)extends from floor (356) and is disposed between ends of outer tray wall(346, 348). Base end wall (360) is sized for reception within tray space(338). Base end wall (360) defines aperture (362) through which a tissuesample may be received from, for example, cutter (200) via port (306) asdescribed above. Floor (356), outer tray walls (346, 348), an undersideof wall (352), and base end wall (360) define tissue sample receivingspace (364). Apertures (358) of arcuately shaped floor (356) may be ofany suitable shape and size. For example, apertures (358) may have acircular shape and be sized large enough such that fluids from a tissuesample received in tissue sample receiving space (364) may flow throughapertures (358) to fluid receiving space (366) while the tissue sampleremains in tray (340) positioned within tray space (338). Fluidreceiving space (366) is formed, as shown in FIG. 7, by front portionsof the interior face of walls (320, 322), elongate protrusions (336), anunderside of ledge (334), the interior face of the distal portion ofcentrally disposed wall (324), and floor (356) of tray (340). Fluidreceiving space (366) is disposed over vacuum port (307) of probe (100)when housing (304A) is rotated to position tissue sample chamber (345A)over port (306). The fluid may then flow back through biopsy device (10)through to tubes connected to vacuum source (800).

In use, an initial set of tissue samples may be received and piled intobulk chamber (308), disposed over and aligned with port (306) of probe(100). Inner housing (304A) with bulk chamber (308) disposed over port(306) may be automatically indexed, via motor (301) as described above,for example, after each receipt of a tissue sample through port (306).Eventually, inner housing (304A) will be indexed to a point at whichtissue sample chamber (345A) will be disposed over and aligned with port(306), instead of a portion of bulk chamber (308), to receive a tissuesample. At this point, after a first set of tissue samples are receivedin bulk chamber (308), the sample received in tissue sample chamber(345A) may be treated as a pathological sample for lab testing purposes,for example, and the samples received in bulk chamber (308) may bediscarded. A similar use may occur in and for any of the inner housingexamples of the present disclosure, in which samples received withintissue sample chambers may be pathological samples for further testing(such as an oncology sample stored in formalin prior to testing) andsamples received in bulk chamber (308) may be discarded.

V. Exemplary Second Version of an Inner Housing for a Tissue SampleHolder

FIGS. 9-11 show another exemplary version of inner housing (304B) fortissue sample holder (300) of biopsy device (10). Exemplary innerhousing (304B) is positioned over port (306), as described above forinner housing (304A). The reference numbers used for like components ofinner housing (304A) are also used for inner housing (304B). Further,the similarities between the versions herein will generally not befurther discussed. When tray (370) is received in tray spaces of innerhousing (304B), the proximal end view is similar to the proximal endview shown in FIG. 6 for inner housing (304A). From a distal view ofinner housing (304B), however, or when tray (370) is not received withinthe tray spaces of inner housing (304B), the inner housing (304B)differs from inner housing (304A) in that it includes three tissuesample chambers (345B) rather than just one such chamber (345A). Innerhousing (304B) also includes a bulk chamber (308). Tissue samplechambers (345B) are separated from bulk chamber (308) by walls (320,322, 324). Walls (320, 322) project inwardly from interior wall face(314) of outer annular wall (310) of inner housing (304A), and wall(324) is disposed between end portions of walls (320, 322). While wall(324) is shown as arcuately shaped, wall (324) may be formed to includeother shapes apparent to those of ordinary skill in the art.

The second version of inner housing (304B) of tissue sample holder (300)further includes interior walls (372, 374) disposed between inwardlyextending walls (320, 322) and extending between interior wall face(314) of outer annular wall (310) and centrally disposed wall (324) todefine three tissue sample chambers (345B). While three such chambersare shown in this example, more or fewer interior walls may be includedto define a greater or fewer number of chambers, respectively. Interiorfaces of walls (320), (324) and interior wall (372) along with firstportion (P1) of interior wall face (314) of outer annular wall (310)define a first tissue sample chamber (345B). An opposite face ofinterior wall (372), an interior face of centrally disposed wall (324),and a face of interior wall (374), along with second portion (P2) ofinterior wall face (314), define a second tissue sample chamber (345B).An opposite face of interior wall (374), interior faces of walls (322,324), and third portion (P3) of interior wall face (314) define a thirdtissue sample chamber (345B). Exterior faces of walls (320, 322, 324)face towards fourth portion (P4) of interior wall face (314) and, withthe fourth portion, define bulk chamber (308).

As shown in FIG. 10 and similar to the first version, interior faces ofinwardly projecting walls (320, 322) as well as the faces of interiorwalls (372, 374) each include front portion (F), rear portion (R), andan elongated protrusion (336) internally extending from the upperportion of each of the walls. Elongated protrusions (336), the rearportions of walls (320, 322, 372, 374), and interior wall face (314) ofouter annular wall (310) together define a distal end of three separatetray space cavities (376, 378, 380) for receiving and retaining threerespective prongs (382, 384, 386) of removable tray (370), respectively,as described below. As shown in FIG. 11, the rear portions of walls(320, 322, 372, 374), first, second, and third portions (P1, P2, P3) ofinterior wall face (314) of outer annular wall (310), and the interiorface of the upper portion of centrally disposed wall (324) togetherdefine a proximal end of tray space cavities (376, 378, 380) torespectively receive prongs (382, 384, 386) of removable tray (370).

Tray (370), as shown in FIG. 11, includes handle (342) proximallyextending from arcuate and elongate proximal end wall (344). Outer traywalls (390, 392) of first prong (382), outer tray walls (390, 392) ofsecond prong (384), and outer tray walls (390, 392) of third prong (386)each project distally from an underside of proximal end wall (344). Apair of arcuate walls (394, 396) is disposed distal and proximate toproximal end wall (344) for each of the prongs. External peripheral endsof proximal end wall (344) and arcuate walls (394, 396) act as wiperseals providing an additional seal between the proximal end of tray(370) and tissue sample chambers (345B) when the three prongs (382, 384,386) of tray (370) are respectively received in tray space cavities(376, 378, 380) defined by walls of tissue sample chambers (345B) toprevent potential seepage of tissue sample liquid or the tissue sample;and also help to maintain a vacuum within chambers (345B). Theperipheral ends may, for example, form a frictional fit with the wallsof tray space cavities (376, 378, 380) of inner housing (304A). Tray(370) and/or other components of tissue sample holder (300) may alsoinclude face seals and/or various types of elastomers to create a seal.

Floors (398) are disposed between each set of outer tray walls (390,392) and include apertures (404). At a distal end, each of the prongsincludes base end wall (406) extending from a respective floor (398).Each base end wall (406) is disposed between ends of respective outertray walls (390, 392). Base end walls (406) are each sized for receptionwithin respective tray space cavities (376, 378, 380). Base end walls(406) each include internal walls defining aperture (408) through whicha tissue sample may be received from, for example, cutter (200) asdescribed above. For each prong, floor (398), outer tray walls (390,392), an underside of wall (396), and base end wall (406) define atissue sample receiving space (410). Apertures (408) of arcuately shapedfloor (398) are sized in a manner similar to that described above forthe first version.

In use, inner housing (304B) may be indexed in a manner similar to innerhousing (304A) such that bulk chamber (308) may initially be disposedover port (306) of probe (100) to receive tissue samples and innerhousing (304B) may be indexed after each such receipt until one oftissue sample chambers (345B) receive a tissue sample. Further, indexingmay continue until each of tissue sample chambers (345B) have received arespective tissue sample for potential pathological uses, such as use asan oncology sample stored in formalin prior to testing, while tissuesamples received in bulk chamber (308) may be discarded. Suchauto-indexing toward and receipt into multiple tissue sample chambers ispossible for the inner housing examples disclosed herein that includemultiple tissue sample chambers.

VI. Exemplary Third Version of an Inner Housing for a Tissue SampleHolder

FIGS. 12-14 show another exemplary version of inner housing (304C) fortissue sample holder (300) of biopsy device (10). The reference numbersused for like components of inner housings (304A, 304B) are also usedfor inner housing (304C). Further, the similarities between the versionswill generally not be further discussed.

Referring to FIG. 12, a proximal view of inner housing (304C) shows tabs(412) transversely extending from proximal surface (414) of innerhousing (304C). FIG. 13 shows a distal view of inner housing (304B) whentray (416) is removed from tray spaces of inner housing (304B), alongwith plug (418), bulk chamber cap (420), outer cup (303), and gear shaft(422). One way that inner housing (304C) differs from inner housing(304A) is that inner housing (304C) includes two tissue sample or trayreceiving chambers (345C) and a plug chamber (424) along with bulkchamber (308) rather than a single tray receiving chamber along withbulk chamber (308).

Bulk chamber cap (420) is configured to correspond with a shape of bulkchamber (308) to seal bulk chamber (308). Bulk chamber cap (420)includes a recessed portion having a corresponding shape with a profiledefined by walls (320, 322, 324). Cap (420) includes proximal surface(426) (FIG. 14) and distal surface (428) (FIG. 13) and three walls (430,432, 434) disposed therebetween. As shown in FIG. 16, first longitudinalwall (430) extends from distal surface (428) to transverse wall (432).Transverse wall (432) transversely extends between first longitudinalwall (430) and second longitudinal wall (434). Second longitudinal wall(434) extends from proximal surface (426) of cap (420). Firstlongitudinal wall (430) is shaped to abut interior wall face (314) ofinner housing (304C) and exterior faces of walls (320, 322, 324).Transverse wall (432) of cap (420) is shaped to abut portions ofproximal surface (414) of inner housing (304C) and tabs (412). When cap(420) is disposed over inner housing (304C), cap (420) may connect toinner housing (304C) in a frictional fit connection, for example,between first vertical wall (430) of cap (420), interior wall face (314)of inner housing (304C), and exterior faces of walls (320, 322, 324). Bylongitudinal wall (432) of cap (420) extending and being disposed overtabs (412), the removal of cap (420) may be facilitated by allowing fora space under a portion of longitudinal wall (432) of cap (420) when cap(420) is seated to inner housing (304C) such that force sufficient tolift cap (420) from inner housing (304C) may be applied to the exposedportion of horizontal wall (432). FIG. 14 shows a view of cap (420)seated against inner housing (304C) when tissue sample holder (300) isassembled to include cap (420), inner housing (304C), outer cup (303),and gear shaft (422).

Proximal surface (426) of cap (420) includes handle (436) (FIG. 14),which allows for assistance with seating or removing cap (420) frominner housing (304C). Handle (436) may also be used to facilitate manualrotation of inner housing (304C) within outer cup (303) in versionswhere inner housing (304C) is manually rotatable. In the presentexample, however, rotation of inner housing (304C) is provided by motor(301) via shaft (422). As with the rotation described above for thefirst tissue sample holder version, inner housing (304C) may be rotateduntil one of tissue sample chambers (345C) of FIG. 12 is disposed overport (306) as shown in FIG. 5, such that tissue samples may be receivedwithin the selected tissue sample chamber (345C). Alternatively, innerhousing (304C) may be rotated until plug chamber (424) is disposed overthe sample entry point to deliver an item or material, such as a markerand/or a medication, via delivery means such as a marker deployer, whichmay be constructed and operable in accordance with the teachings of U.S.Patent App. Pub. No. 2009/0209854, entitled “Biopsy Method”, publishedAug. 20, 2009, the disclosure of which is incorporated by referenceherein. Plug (418) is configured for receipt within plug chamber (424)when a marker or medication is not being deployed by a deployer, asdescribed above, and acts to seal plug chamber (424) while tissue sampleis received in one of tissue sample chambers (345C). Plug (418) includespost (438) having aperture (440) extending therethrough and handle (442)disposed at a proximal end of post (438). Post (438) of plug (418)defines elongated slot (444), which may be open to aperture (440) orwhich may restrict access to aperture (440) via a slot door.

Referring back to FIG. 12, inner housing (304C) includes tissue samplechambers (345C), plug chamber (424), and bulk chamber (308). Tissuesample chambers (345C) and plug chamber (424) are separated from bulkchamber (308) by walls (320, 322, 324). Walls (320, 322) projectinwardly from interior wall face (314) of outer annular wall (310) ofinner housing (304A), and wall (324) is disposed between end portions ofwalls (320, 322). While wall (324) is shown as arcuately shaped, wall(324) may be formed to include other shapes apparent to those ofordinary skill in the art.

Inner housing (304C) of the present example further includes interiorwalls (372, 374) disposed between inwardly extending walls (320, 322)and extending between interior wall face (314) of outer annular wall(310) and centrally disposed wall (324) to define two tissue samplechamber (345B) and plug chamber (424). While two tissue sample chambersare shown in this example, more or fewer interior walls may be includedto define a greater or fewer number of tissue sample chambers,respectively. Additionally, while a single plug chamber is shown in thisexample, more interior walls may be included to define a greater numberof plug chambers as desired. And while the tissue sample chambers areillustrated to have a generally trapezoidal shape and the plug chamberis illustrated as having an annular shape, other shapes, sizes, andconfigurations for the chambers are within the scope of this disclosure.

As an alternative to a third tissue sample chamber (345B) of innerhousing (304B), inner housing (304C) includes annular plug chamber (424)defined by an opposite face of interior wall (374), interior faces ofwalls (322, 324), and third portion (P3) of interior wall face (314).

The proximal portion of centrally disposed wall (324) is disposedbetween proximal portions of walls (320, 322) and a distal portion ofwall (324) includes transversely extending ledge (445) from which threeextensions (450) distally project and extend towards floor (446) ofcentral piece (448). Floor (446) transversely extends from wall (324)and extensions (450) of wall (324). Floor (446) includes edges (452)demarcating an area indicating a line of separation between proximal anddistal portions of walls (320, 322), respectively. Floor (446) includesan annular portion (454) projecting from edges (452). Annular ramp wall(456) distally projects from annular portion (454) of floor (446) alongdistal portions of walls (320, 322) to sump floor (458), which includesapertures (460) through which fluids or liquid may be suctioned throughand removed from inner housing (304C).

Lower, distal portions of walls (320, 322), fourth portion (P4) ofinterior wall face (314) of inner housing (304C), and an outer edge ofsump floor (458) define space (462) through which tissue sample may bereceived into bulk chamber (308). Post (464) projects from a distalsurface of floor (446), as shown in FIG. 13. Post (464) is sized forreceipt into a proximal aperture (not shown) of gear shaft (422). Theproximal aperture is shaped and sized to receive post (464) in a keyedrelationship. The keyed relationship allows rotation of gear shaft (422)to rotate post (464), which in turn rotates inner housing (304C) withinouter cup (303). The rotation is effected by shaft (422) meshing with acomponent of rotation mechanism (302) driven by motor (301). Of course,rotation may alternatively be provided in any other suitable fashion byany other suitable components/techniques.

As shown in FIG. 13 and similar to the second version shown in FIG. 10,interior faces of inwardly projecting walls (320, 322) as well as thefaces of interior walls (372, 374) each include front portion (F), rearportion (R), and an elongated protrusion (336) internally extending fromthe upper portion of each of the walls. Elongated protrusions (336), therear portions of walls (320, 372, 374), and interior wall face (314) ofouter annular wall (310) together define a distal end of two separatetray space cavities (466, 468) for receiving and retaining tworespective prongs (470, 472) of removable tray (416A), respectively, asdescribed below. As shown in FIG. 12, opposite proximal end of trayspace cavities (466, 468) respectively receive prongs (470, 472) ofremovable tray (416) (FIG. 13). The proximal end of tray space cavities(466, 468) is defined by the rear portions of walls (320, 372, 374),first and second portions (P1 and P2) of interior wall face (314) ofouter annular wall (310), and the interior face of the upper portion ofcentrally disposed wall (324).

Tray (416A), as shown in FIG. 13, includes handle (474) proximallyextending from arcuate and elongate proximal end wall (476). Outer traywalls (478, 480) of first prong (470) and of second prong (472) eachproject distally from an underside of proximal end wall (476). Arcuatewalls (482) are disposed distal of and proximate to proximal end wall(476) for each of the prongs. External peripheral ends of proximal endwall (476) and arcuate walls (482) act as wiper seals providing anadditional seal between the proximal end of tray (416A) and tissuesample chambers (345C) when the prongs (470, 472) of tray (416A) arerespectively received in tray space cavities (466, 468) defined by wallsof tissue sample chambers (345C) to prevent potential seepage of tissuesample liquid or the tissue sample; and also help to maintain a vacuumwithin chambers (345C). The peripheral ends may, for example, form africtional fit with the walls tray space cavities (466, 468) of innerhousing (304C). Tray (416A) and/or other components of tissue sampleholder (300) may also include face seals and/or various types ofelastomers to create a seal.

Floors (484) are disposed between each set of outer tray walls (478,480) and include apertures (486). Each of the prongs includes base endwall (488) extending from a respective floor (484) at a distal end. Eachbase end wall (488) is disposed between ends of respective outer traywalls (478, 480). Base end walls (488) are each sized for receptionwithin respective tray space cavities (466, 468). Base end walls (488)each include internal walls defining aperture (490) through which atissue sample may be received from, for example, cutter (200) asdescribed above. For each prong, floor (484), outer tray walls (478,480), an underside of arcuate wall (482), and a proximal surface of baseend wall (488) define a tissue sample receiving space (492). Apertures(486) of arcuately shaped floor (484) are sized in a manner similar tothat described above for apertures (358) of the first version.Similarly, fluids from a tissue sample received in tissue samplereceiving spaces (492) via port (306) of probe (100) may flow throughapertures (486) to respective fluid receiving spaces (494) while thetissue sample remains in a respective prong of tray (416) positionedwithin a respective tray space. Fluid receiving spaces (494) are formed,as shown in FIG. 13, by front portions (F) of the interior face of walls(322, 372, 374), elongate protrusions (336), an underside of ledge(445), the interior face of extensions (450) of the distal portion ofcentrally disposed wall (324), and floor (484) of prongs (470, 472) oftray (416A). The fluid may then flow back through biopsy device (10) viavacuum port (307) as described above through to tubes connected tovacuum source (800).

VII. Exemplary Fourth Version of an Inner Housing for a Tissue SampleHolder

FIGS. 15-16 show another exemplary version of inner housing (304D) fortissue sample holder (300) of biopsy device (10). The reference numbersused for like components of inner housings (304A, 304B, 304C) are alsoused for inner housing (304D). Further, the similarities between theversions herein will generally not be further discussed.

Inner housing (304D) differs from the inner housing (304C) in that innerhousing (304D) includes a single tissue sample chamber (345D) along withplug chamber (424) rather than multiple tissue sample chambers. Innerhousing (304D) may include a proximal surface seated to cap (420) in amanner similar to that described for inner housing (304C). FIG. 15 showsan alternative proximal surface of inner housing (304D) in which bulkchamber (308) is sealed by upper floor (500) disposed within an upperperiphery of outer annular wall (310) of inner housing (304D) such thattissue sample chamber (345D) and plug chamber (424) are in communicationwith apertures defined in upper floor (500).

FIG. 16 shows a distal end of inner housing (304D). Walls (320, 502)define tissue sample chamber (345D) along with a first portion ofinterior wall face (314) of outer annular wall (310). Walls (322, 502)define plug chamber (424) along with a second portion of interior wallface (314) of outer annular wall (310). Ribs (504) extend from aninterior face of wall (324) towards the first portion of interior wallface (314) to a length sufficient to abut floor (484) of tray (416B)when tray (416B) is received within the rear portion of tissue samplechamber (345D) in a manner similar to that described above for thefourth version. Additionally, tray (416B) is similar to tray (416A)described above for the fourth version except that tray (416B) includesa single prong rather than two prongs and includes a plurality of bins(506) disposed between end wall (476) and arcuate wall (482). Further,tissue sample receiving space (492) for tray (416B) is sized to receiveseveral tissue samples while each tissue sample receiving space (492)for tray (416A) was sized for receipt of only a single tissue sample.

VIII. Exemplary Fifth Version of an Inner Housing for a Tissue SampleHolder

FIGS. 17-18 show another exemplary version of inner housing (304E) fortissue sample holder (300) of biopsy device (10). The reference numbersused for like components of inner housings (304A, 304B, 304C. 304D)previous versions are also used for inner housing (304E). Further, thesimilarities between the versions herein will generally not be furtherdiscussed.

Inner housing (304E) includes tray receiving chambers (345E), or tissuesample chambers, that are configured to receive trays (416B). Trays(416B) are similar to the single-prong tray (416B) received in innerhousing (304D) and generally will not be discussed further.

Referring to FIG. 17, plug chamber (424) is defined at a proximal endwithin wall (600) that is disposed between first and second tissuesample chambers (345E). A third tissue sample chamber (345E) is disposedbetween and separated from first and second tissue sample chambers(345E) via walls (602, 604). Each of walls (600, 602, 604) extendbetween interior annular wall (606) and outer annular wall (310). Ledge(608) transversely extends from a central portion of interior annularwall (606) and includes distally extending annular extension (610) andvertical extensions (612) that extend to floor (614). Similar to thefourth version, and as shown in FIG. 18, post (464) distally projectsfrom floor (614). Referring to FIG. 18 showing a distal view of innerhousing (304E), tissue sample chambers (345E) and plug chamber (424)include front portions (F) and rear portions (R). Distal ends of walls(600, 602, 604) include protrusions (336) as described above withinprevious versions. Vertical ribs (616) project from interior annularbase (618) towards interior wall face (314) of outer annular wall (310)to a distance similar to the distance protrusion (336) is positioned ona respective wall with respect to interior annular base (618). Ribs(616) include a T-shaped profile such that an inside portion verticallyextends from interior annular base (618) disposed below floor (614) andan end portion adjacent the inside portion has a width greater than thewidth of the inside portion. Referring back to FIG. 17, end portions ofribs (616) extend distally from projections (620) disposed on interiorannular wall (606). Spaces defined by ribs (616), an underside of ledge(608), and annular base wall (622) extending between interior annularbase (618) and floor (614), as well as spaces defined by walls (600,602, 604), an underside of ledge (608), and at least one rib (616), arefluid receiving spaces (494) that operate in a manner as described abovefor fluid receiving spaces of previous examples.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1. A biopsy device, the biopsy device comprising: (a) a probe body; (b)a needle portion extending distally from the probe body, wherein theneedle portion comprises a transverse tissue receiving aperture; (c) ahollow cutter positioned within the needle portion, wherein the cutteris translatable within the needle portion to sever a tissue sample fromtissue protruding through the aperture, wherein the hollow cutterdefines a cutter lumen; and (d) a tissue sample holder, wherein thetissue sample holder comprises: (i) at least two tissue sample chambersand at least one plug chamber, wherein each of the chambers extends inan axial direction, wherein the axial direction is parallel with thecutter lumen, wherein the at least one plug chamber is configured toreceive a plug when at least one of the tissue sample chambers isconfigured to receive a tissue sample, and (ii) at least one trayremovably engaged with at least one of the tissue sample chambers,wherein the at least one tray is removable from the tissue samplechamber in an axial direction, wherein the tissue sample holder isoperable to selectively index a tissue sample chamber with the cutterlumen to receive the tissue sample in the indexed chamber.
 2. The biopsydevice of claim 1, wherein the tissue sample holder further comprises aninner housing, wherein the inner housing defines the chambers, whereinthe at least one tray is removably engageable with at least one of theat least two tissue sample chambers of the inner housing.
 3. The biopsydevice of claim 1, wherein the at least one tray comprises at least oneprong, the prong comprising a pair of sidewalls, a base end wallextending between each pair of sidewalls, and a floor integral with eachpair of sidewalls and corresponding base end wall.
 4. The biopsy deviceof claim 3, wherein one of the at least two tissue sample chambers issized to receive the at least one prong of the tray.
 5. The biopsydevice of claim 3, wherein the tray comprises at least a first prong anda second prong, and the tissue sample holder comprises at least a firstchamber and a second chamber, wherein the first tissue sample chamber issized to receive the first prong and the second tissue sample chamber issized to receive the second prong.
 6. The biopsy device of claim 1,wherein at least part of the tissue sample holder is sized to fit into aformalin cup.
 7. The biopsy device of claim 1, wherein each traycomprises at least one prong, and each prong defines a tissue samplereceiving space, wherein each tissue sample receiving space of eachprong is associated with a corresponding tissue sample chamber.
 8. Thebiopsy device of claim 1, wherein the tissue sample holder is configuredto redirect fluid communicated to the cutter lumen from a firstdirection to a second direction.
 9. The biopsy device of claim 1,wherein the tissue sample holder is selectively engageable with theprobe body, wherein the tissue sample holder comprises a releasemechanism operable to selectively release the tissue sample holderrelative to the probe body.
 10. The biopsy device of claim 1, whereinone of the at least two tissue sample chambers defines a first chamberhaving a first volume, the other of the at least two tissue samplechambers defines a second chamber having a second volume, and the firstvolume differs from the second volume.
 11. The biopsy device of claim10, wherein the first volume is substantially greater than the secondvolume.
 12. The biopsy device of claim 11, wherein the first chamber isa bulk chamber configured to receive multiple tissue samples.
 13. Thebiopsy device of claim 12, wherein the second chamber is configured toreceive only a single tissue sample.
 14. The biopsy device of claim 12,wherein the second chamber is configured to receive at least one lesstissue sample than the bulk chamber.
 15. The biopsy device of claim 1,wherein the tissue sample holder is configured to redirect fluid fromthe cutter lumen to a vacuum lumen.
 16. A tissue sample holderconfigured to engage a biopsy probe and receive a tissue sample, thetissue sample holder comprising: (a) a housing including at least afirst chamber and a second chamber, wherein the chambers each extendalong an axial direction, and wherein the first chamber has a firstvolume, the second chamber has a second volume, and the first volumediffers from the second volume; and (b) at least one tray, wherein thetray is configured to be axially received within at least one of thechambers, wherein the at least one tray is configured to receive atissue sample.
 17. The tissue sample holder of claim 16, wherein thehousing further comprises: (i) an outer member having a proximal edgeand a distal edge, wherein the outer member defines a central bore, (ii)a plurality of radially extending walls extending from the outer member,and (iii) an inner member extending between inner ends of the pluralityof radially extending walls, the inner ends spaced from the outermember, wherein the outer member, the inner member, and the walls defineat least one of the at least two tissue sample chambers; wherein a firstportion of the outer member, the inner member, a first outer wall of theplurality of walls, and a second outer wall of the plurality of wallsdefine a first chamber, wherein a second portion of the outer member,the inner member, and at least two of the walls of the plurality ofwalls define a second chamber of the at least two chambers, and whereinthe first chamber is separate from the second chamber.
 18. The tissuesample holder of claim 17 wherein each chamber of the chambers comprisesa proximal end and a distal end, wherein the proximal end is configuredto receive a tray, wherein the distal end is configured to be positionedproximate to the probe, wherein the plurality of radially extendingwalls in the housing extend between the proximal end and the distal end.19. The tissue sample holder of claim 17, wherein the at least one traycomprises: (i) a pair of sidewalls, each sidewall having a proximal edgeand a distal edge, (ii) a base end wall engaged with the sidewalls, thebase end wall having a proximal edge and a distal edge, the base endwall defining an aperture, and (iii) a floor coupled to the proximaledges of the sidewalls and the proximal edge of the base end wall;wherein the tray is configured to be received within a chamber of the atleast two tissue sample chambers and the distal edges of the sidewallsof the tray are configured for receipt into the respective chamber. 20.A method of operating a biopsy device, the biopsy device comprising: (i)a needle having a tissue receiving aperture, the needle defining aneedle axis, (ii) a cutter configured to sever tissue at the aperture,(iii) a lumen configured to communicate tissue severed by the cutter,and (iv) an inner housing for a tissue sample holder having a bulkchamber and a tray chamber, the bulk chamber having a greater volumethan the tray chamber, the tray chamber having at least one trayconfigured to receive tissue communicated through the lumen via an entrypoint, the method comprising: (a) capturing a tissue sample with theneedle and the cutter; (b) communicating the tissue sample through thelumen to the bulk chamber via the entry point; (c) rotating the innerhousing to reposition the inner housing relative to the entry point; (d)repeating steps (a)-(c) until the tray is disposed over the entry point;(e) communicating a tray tissue sample through the lumen to the tray viathe entry point; and (f) removing the tray from the tissue sample holderby pulling the tray in an axial direction parallel to the needle axis.